MPN NA Issue 16 by MPN Magazine

NORTH AMERIC AN EDITION

MEDICALâ&#x20AC;&#x2C6;PLASTICS + news THE BUSINESS CASE FOR HOSPITALS TO RECYCLE PETG MEDICAL TRAYS NEW CALIFORNIA LAW IMPACTS MANUFACTURERS AND DISTRIBUTERS SURGICAL TRAINING MEETS COVID DEMANDS

AND REDUCE RISK

HUSKY INJECTION MOLDING SYSTEMS HITS US WITH ITS BEST SHOT ISSUE 16

Oct/Nov/Dec 2020

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ADVANCING MEDICAL PLASTICS

CONTENTS MPN North America | Issue 16 | Oct/Nov/Dec 2020

Regulars

Features

3 Comment Rob Coker introduces the final 2020 edition of Medical Plastics News – North America.

12 R&D Budgets: Digital is pivotal Protolabs’ Chris Stevens asks what digital manufacturing means.

5 Opinion Aaron Johnson, VP of Marketing and Customer Strategy, Accumold, considers the variables of micro molding design. 6 Digital spy 9 Thermoforming: Tray, tray again Chandler Slavin, Sustainability and Marketing Director, Dordan Manufacturing, discusses the business case for hospitals to recycle PETG medical trays. 10 Scale up and reduce risk Husky Injection Molding Systems introduce its innovative ULTRASHOT technology, which enables molders to scale-up faster than they thought was possible. 32 Back to the future

17 Smart manufacturing: Putting the “smart” into smart manufacturing Web Industries’ VP of Corporate Development & Medical, Kevin Young, and Market Development and Strategy Manager, Ralph Tricomi, explain how experienced contractors can drive PPE and LFI tests rapidly. 22 Labeled safe Polyfuze describes how Fusion Labeling contributes to healthcare industry commitments through creating sterile environments. 28 Saving lives with science DuPont’s Jennifer Gemo and Eugenio Toccalino share the launch of the new Liveo brand and discuss collaboration, science and materials in nextgeneration medical devices.

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CYROLITE速 has been working in hospitals and

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This has impressed both patients and healthcare professionals alike: CYROLITE速 meets the requirements of USP Class VI, ISO 10993-1, and REACH. You can find more details at www.cyrolite.com.

CREDITS editor | robert coker robert.coker@rapidnews.com advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales plastics & life sciences | lisa montgomery

Editor’s Comment

head of studio & production | sam hamlyn

ROB COKER

graphic design | matt clarke junior designer | ellie gaskell publisher | duncan wood

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ISSN No: 2632 - 3818 (Print) 2632 - 3826 (Digital)

A YEAR TO FORGET/REMEMBER (DELETE AS APPROPRIATE)

ello, greetings, and welcome to 2020’s final edition of Medical Plastics News – North America, featuring me as Laura’s understudy. There is a light at the of the tunnel and, by the time the next edition is out, we will all be glad that 2020 is over – banished to the annuls of history as nothing more than a long series of strange and awful memories. We have a saying here in the UK: ‘Cor blimey, governor!’, which you may have heard someone say in a mockney accent on The Simpsons. I think it summarises, succinctly, the year very well, given the rather catastrophic failures of some Western governments in their handling of the COVID-19 pandemic. Are we still allowed to criticise governments in a democracy? Oh well. I’ve said it now. Conflicting information, confusing messages, further discreditation of experts and professionals, large-scale protesting and rioting, societal division, blame-shifting and medicalrelated publicity stunts – 2020 really has been a year of challenges for the healthcare and medical industries. The ongoing situation has brought more than just illness and death to those unfortunate persons that have caught the virus. Mental health issues have been playing in its wake like a pod of delinquent dolphins. Whether through the loneliness of self-isolation, the anxiety of being unable to visit vulnerable loved ones, or through missed treatments, both patients and healthcare officials around the world have been pushed to their limits. So, who have been the players stepping up to these challenges if not those in government? Those in science and industry, of course. This is why Husky Injection Molding Systems kindly agreed to provide the inspiration for this edition’s cover. The new UltraShot technology

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has enabled the company to get much-needed, difficult to produce, injection molded parts to market fast. “You’ve basically leap-frogged 3D printing?” I asked Global Business Manager Dr Mike Ellis. “Sure,” he replied. The need for collaborative manufacturing has also stepped up a gear in 2020, I’ve noticed, and within these pages Kevin Young and Ralph Tricomi of Web Industries discuss the importance of experienced contractors in driving PPE and LFI tests rapidly in order to get them where they need to be. As well as all-important regulatory updates – herein provided by Maetrics President Steve Cottrell, and Spencer Fane lawyers Karen Olsen and Jon Farnsworth – DuPont materials scientists Jennifer Gemo and Eugenio Toccalino discuss the launch of its new Liveo brand and the ongoing virtues of science and collaboration in medical applications. We have another saying here: ‘Muck in’, meaning ‘Get involved’ – and that’s the main message I’ve been reading about from the industry. No blame-shifting, no finger-pointing. Just a full-on co-ordinated endeavour to find innovative approaches to dealing with societal challenges. When the going gets tough, the tough muck in. See you in 2021, governor.

Mental health issues have been playing in the wake of the pandemic like a pod of delinquent dolphins 3

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OPINION

PINION DESIGN FOR MICRO MOLDING AARON JOHNSON, VP OF MARKETING AND CUSTOMER STRATEGY, ACCUMOLD, CONSIDERS THE VARIABLES OF MICRO MOLDING DESIGN, AND THE IMPORTANCE OF EARLY PLANNING.

icro molding projects are complicated by their nature, and the fact that many require the repeatable attainment of extremely high tolerances demands that there is a collective focus on accuracy when looking at fabrication, molding, validation, and automation. However, material selection and design for micro molding (DfMM) are also vital. It is because of this that manufacturers work with micro molders as close to the beginning of the product development process as possible. Accessing expert micro molding design insight early is the key to costeffective, timely, and right-first-time manufacturing. Many OEMs view Accumold and other practitioners as manufacturers. While this seems self-evident, we view ourselves more as consultants. Micro molding experts are truly vertically integrated with all stages of product development, and have expertise in design, tooling, molding, validation, and automation. What this brings is pooled expertise, and the best time to do this is at the conceptual design stage. As manufacturers begin to conceive a micro molding project, it is important to bear in mind some key issues from the start. Every project should begin with the end in mind. You need to understand the basic design approach, really bottom out what you can and cannot do. When micro molding, even the smallest design change can be catastrophic. As a rule of thumb when looking at the DfMM, dimensionally at Accumold we can accommodate parts up to half an inch (13mm) in the largest dimension, and to date the smallest we have molded is 0.031” x 0.012” x 0.015” (800 x 300 x 380 microns). Special attention needs to be given to thin wall sections — primarily thick- to thin-wall transitions — as well as on wall thickness uniformity; feature aspect ratios which are highly material dependent; gating; and ejector pins. It is also vital to have an understanding of how shrink rates affect the part, and to be cognizant of parting line mismatch. Taking all this together, there are numerous variables and ‘rules’, but it is important to discuss ideas for micro plastic parts and components with an expert micro molder before abandoning an idea. Micro molding pushes the boundaries of what is possible in manufacturing, and challenges from manufacturers foster innovation. A good micro molder will relish the opportunity to innovate, and only if the objective is truly impossible will they advise design changes. Micro molding materials come in almost as many forms as there are ideas in the mind of a design engineer. In the world of micro molding,

mission-critical components often require exotic or highly engineered compounds. Materials like PEEK, PEI (Ultem), carbon-filled LCP, or glassfilled nylons are commonplace. Soft durometer or elastomeric resins are also prominent. Direct experience with these materials is another part of valuable know-how needed to maximize the performance of the resin/part design combination. The typical route to material selection is to match the functional part requirements with material datasheets. However, most datasheets are based on the manufacture of much larger parts, and this will reflect on recommended gate size and flow properties. So, manufacturers looking to micro mold follow datasheets and then see sub-optimal results when the parts are molded. This can lead to premature design iterations, or, in extreme cases, the abandonment of projects. The central issue is that datasheets, advice from resin suppliers, and part design criteria are all at odds at the micro scale. It is because of this that it is vital to engage with expert micro molders early in the design phase as they are best equipped to advise based on years of experience navigating material selection issues, and are best placed to indicate whether a material could be an issue in production.

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DIGITAL SPY

DIGITAL

spy

www.medovate.co.uk MEDOVATE’S SAFIRA RECEIVES EUROPEAN CE REGULATORY APPROVAL

NEWS UPDATE

www.kraton.com

Kraton’s BIAXAM kills up to 99.99% of microbes Kraton Corporation is seeking regulatory approval for BIAXAM, a novel sulfonated polymer technology with longlasting self-disinfecting properties that has been demonstrated in studies to quickly inactivate up to 99.99% of SARSCoV-2 (virus that causes COVID-19) and other microbes. Kraton developed the BIAXAM technology as part of its sulfonated polymer product line and plans to expand product testing and seek regulatory approval for use as a durable, long-lasting disinfectant from the United States Environmental Protection Agency (EPA).

REGULATORY UPDATE

SVP and CTO Dr Vijay Mhetar said: “BIAXAM offers rapid and longlasting performance, unlike current disinfectant offerings that are only effective immediately or require periodic treatment or re-application. Currently there are no EPA-approved longlasting disinfectants, so this technology is truly extraordinary. We believe the EPA would approve BIAXAM for the US market and allow us to market the solution due to the novel antimicrobial properties it has demonstrated.” The BIAXAM technology is patent-pending and will be commercially available shortly.

Developed in collaboration with anaesthetists in the UK NHS, the device was successfully launched in the US earlier this year, having secured FDA clearance. Medovate has now announced that it has received the CE Mark Approval for its SAFIRA (SAFer Injection for Regional Anaesthesia) medical device. Successful CE certification marks a key milestone for the fast-growing company, itself established just over two years ago. As a UK-based enterprise, this regulatory approval is essential as it continues to expand in territories across the world. The European and American Societies of Regional Anaesthesia have recently produced joint

RECYCLING UPDATE

www.newageindustries.com

NEWAGE INDUSTRIES ANNOUNCES PLAN TO RECYCLE SILICONE TUBING WASTE Plastic and silicone tubing manufacturer NewAge Industries is now able to recycle the waste from its silicone tubing and braid reinforced hose extrusion processes. NewAge partners with ECO USA and their silicone recycling plant in Parkersburg, West Virginia. Following transport to the facility, silicone is ground into small pieces, mixed with catalysts and heated to break down its chemical bonds. Liquids from this stage are filtered, refined, polymerized into silicone oils and filtered again. The final product is silicone oil that is comparable to virgin silicone. Production Manager Matt Bauer said: “We’re always looking for ways to reduce manufacturing waste. We’ve been recycling our plastic scrap for years,

COVID-19 recommendations stating that regional anaesthesia should be preferred over general anaesthesia whenever surgery is planned for suspected or confirmed COVID-19 patients. In enabling regional anaesthesia to be carried out as a one-person procedure, SAFIRA further complements these recent recommendations.

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but recycling silicone can be complicated. Producing silicone oil from silicone tubing is a multistep reclamation process that few companies are doing.”

DIGITAL SPY

APPOINTMENT UPDATE

www.guill.com

Guill introduces reciprocating head Guill Tool has released its new reciprocating head wherein the traditional tip and die assembly is replaced with a linear reciprocating assembly that changes the tube’s profile within a given length.

there is no need for storage of various tubing shapes and connectors.

talking

POINT

Furthermore, the reciprocating head eliminates a connecting piece, and allows JIT production and products made-to-order.

This process is repeated throughout a single extrusion run without interruptions. While cost and value stream activities are reduced, quality is improved. Only one extrusion run is needed to produce a finished product.

www.gcaesthetics.com

Fara Naomi Macias, Head of Marketing, GC Aesthetics

Guill’s new reciprocating head eliminates an assembly operation and eliminates in-process inventory. Thus,

What’s new in the world of women’s health? The power to choose, with information and assessing benefits and risks. Every woman is different and every case requires its unique approach.

EXTRUSION UPDATE

How do women’s health products differ now from those of yesteryear, and what has driven these changes? I would say the standards remain: being vigilant, safety standards, following up on data. What has changed is that there is a lot more information out there and information is power.

chromacolors.com AND www.epolin.com

CHROMA COLOR ANNOUNCES NEW EXECUTIVE TEAM APPOINTMENT Mike Crosby has joined Chroma Color Corporation from BASF, where he worked as Global Industry Manager for the Colors & Effects business. Crosby will take on the role of VP and GM of Epolin, working closely with Greg Amato who has led Epolin since 2004 and will be

staying with the business through the transition. Amato plans to retire in 2021. CEO Tom Bolger said: “Epolin has added a strategic, technical depth to Chroma and, under Mike’s leadership, we will strive to continually improve our value to existing customers.”

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You have a history in medical device copywriting, how has this helped you in your current role? The basis of a good leader is communication and having the ability to communicate thru written forms is magic. Good leaders communicate clearly, give well-defined instructions and feedback. Also, being a former copywriter helps you understand who we are selling to and how, and this is a key differentiator. How will the medical plastics industry benefit from putting more women in leading positions? It’s a well-documented fact that having women in leadership roles is good for business, but specifically in healthcare and aesthetics. I believe our gender’s pursuit for equality benefits the industry. As women we are aware of our needs, desires and hopes for ourselves, our bodies and our future. Gender shouldn’t be a factor in whether or not someone can be a great leader — the leadership abilities should depend on individual strengths. I truly believe that in this business, more women should be leading.

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THERMOFORMING

TRAY, TRAY AGAIN SUSTAINABILITY AND MARKETING DIRECTOR OF DORDAN MANUFACTURING CHANDLER SLAVIN DISCUSSES THE BUSINESS CASE FOR HOSPITALS TO RECYCLE PETG MEDICAL TRAYS.

lastic is a necessity for packaging products for its cost and performance, yet it is also an environmental nuisance because it persists in our natural environment. While consumer packaged goods (CPG) companies, the largest contributors to global plastic packaging waste, work with industry, government, and environmental stakeholders to address the plastic waste problem, they have a long and challenging road ahead. This is because the economics of recycling much post-consumer packaging do not make for a compelling business case, as the cost of collection, sortation, and reprocessing typically outweighs the cost of virgin material production. Though the Ellen Macarthur Foundation is working to change this, by infusing post-consumer plastics with its virgin value such that it is seen as worthy of recovery, actualizing the ‘New Plastics Economy’ will require a fundamental remake to the way we produce and consume products and services. Opportunities for recycling some post-consumer plastic packaging do exist, however. For instance, from 2009 to 2015, Dordan Manufacturing, a thermoformer of consumer and medical packaging, helped make clamshells recyclable. This was accomplished by incorporating PET clamshells into the exiting PET bottle recycling system. By piggy-backing on an already established recycling market, where the demand for PET recyclate exceeded the collected supply, recycling clamshells provided value to recyclers, and therefore became recyclable. The likelihood that a package is recyclable, therefore, depends on the amount generated in the waste stream, the cost of collection, sortation, and reprocessing, and the existence of end markets for the recyclate. Unlike recycling much post-consumer plastic packaging, medical packaging – and specifically PETG trays – is easy to recycle. Because of this, recycling medical packaging provides a revenue stream for hospitals to capitalize on. Through an understanding of the economics of waste management, hospitals can develop a program that diverts medical packaging from landfill, reducing costs and positioning the healthcare provider as a sustainability champion in the community. Recycling medical packaging is independent of the municipally managed and tax-payer-funded, postconsumer stream. It is managed at the commercial level, which means that the hospital is responsible for finding a home for its waste. The cost to hospitals of collecting and sorting PETG trays for resale requires no investment, outside of employee training and the implementation of a container recovery program. Hospitals offer a single point of collection and sortation, providing incentive to buyers of recycled materials to establish partnerships. Recyclers want a consistent and high-quality supply of

material that is easy clean, bale, and resale for profit. PETG trays – the predominant type of medical packaging for medical devices – are made of high-quality plastic. Medical device manufacturers, who sell to hospitals, purchase them in high volume. Because hospitals control the procurement of their medical products, and arguably, the type of packaging being used, opportunity exists to ensure that there is an ample and consistent supply of PETG trays available for resale to recyclers. Dordan is an expert in designing and manufacturing medical packaging for recycling. The thirdgeneration family owned and operated custom thermoformer provides its medical customers with the tools and resources needed to establish a recycling program with hospitals and healthcare facilities. By recycling PETG tray packaging, hospitals are able to reduce waste management costs, redefine its relationship with the products it purchases, and contribute to the circular economy.

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COVER STORY

AND REDUCE RISK TECHNICAL SPECIALIST AT HUSKY SHELDON ALEXANDER INTRODUCES THE INNOVATIVE ULTRASHOT TECHNOLOGY.

s we approach the end of a challenging year for many industries, Husky Injection Molding Systems is introducing its latest technological innovation, the UltraShot Injection System, which has been designed to enable medical customers to mold parts they haven’t been able to in the past, while offering risk-free scalability and innovative part design. Injection molding has not evolved to meet industry demands. Traditional injection molding uses a reciprocating screw, which evolved into a two-stage process, where the melting and injection of the resin are separated to give better control and tighter tolerances. Since this two-stage process was introduced, there has been minimal evolution in injection molding – creating limitations in part design and production – until now. The melt delivery system is one of the most critical elements

in the injection molding cell when it comes to high cavitation molding. Perfect melt management and cavity filling is so key to final part quality and overall equipment efficiency. With the UltraShot, Husky has moved the shooting pots in proximity of the gate, allowing for greater, highly precise molding control. The UltraShot Injection System pressurizes the resin near the cavities, reducing the influence of resin compressibility and shear, and thermal variations on balance and part quality. Eliminating these influences, the UltraShot Injection System achieves industryleading balance and exceptional part quality. The discrete injection circuit design is scalable to 128 cavities, providing the same process conditions regardless of mold size. Elimination of the scaling effects leads to faster qualification time from pilot to product tooling while reducing risk. Compared to conventional hot runners, melt in the UltraShot Injection System experiences fewer high-pressure injection cycles, preserving the original resin properties. This leads to lower molded-in stress and better mechanical and optical properties in the molded part. This is truly revolutionary for the medical market due to a number of key, highly applicable advantages, including the ability to increase scale faster with lower risk, helping customers go to market quicker; increasing yield by reducing scrap rates; eliminating subsequent manufacturing steps; and enabling new part designs and new resins usage – parts can be manufactured based on function not injection molding limitations. DEMANDING BETTER This year, demand for rapid market entry has increased exponentially, and Husky responded by finding – through extensive new market needs and customer research – that global footprint and manufacturing capability is no longer enough. Now manufacturers need technology to allow for scalability enablement. The UltraShot does this through accurate systemic control. Scaling needs to be done carefully and precisely to ensure it is risk-free and economical. With the UltraShot, molders can effectively grow volume in an economical and timely manner while also greatly decreasing the time-to-market process. In the past, due to risk limitations, medical molders would not go directly to the desired, most economical mold cavitation but often increase in multiple intermediate steps. Each step would have to be validated anytime they increase cavitation. This is not a quick process and can often take years to do successfully, plus it is very expensive requiring more equipment and a larger footprint. With today’s market needs, medical molders need to be able to scale-up their capacity quickly, so they can get their product to market. With system level expertise, Husky can help customers leap to the next level of highly efficient production. Husky’s system-level approach team helps to identify the overall production opportunities, develop the suitable solution and then continues to support the process through advanced connectivity tools.

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COVER STORY

The UltraShot can go from a prototype tool directly to a high cavitation system since the system behaviour is identical, regardless of the number of cavities. A big statement, but one that Husky has demonstrated with actions and innovations, as has its customers – with actual production results. One of its global customers, Coloplast, which specialises in the fields of ostomy care, continence care, wound and skin care, and interventional urology, were offered the opportunity to look into the Husky product development process. This led to massive amounts of confidence in their products. Principle Process Engineer at Coloplast Teo Guldbæk said: “Working with Husky is always a pleasure. I’ve been working with Husky since 1993 and it’s always been rewarding. We have found that developing new products for future needs, which before UltraShot we thought was impossible, can be done. The downstream savings are immense, and working with Husky in this UltraShot project is giving us a lot extra. It has given us a real, strong belief in the ideas and how Husky actually works. And it’s been a pleasure.” INNOVATING SAFELY Technology innovation must be connected to two things in the medical industry – Production Advancements and Risk Reduction. We have all witnessed exponential increases in demand driven by COVID-19. When molding medical parts, risk is a major factor in decisions as it directly translates to cost. For example, there have been scenarios wherein huge volumes of parts have had to be scrapped because of risk to human health. How can industry players reduce this risk and eliminate these scenarios? This is where innovation plays a key role. By ensuring parts are more consistent dimensionally, with perfect balance and by having a more stable process. Plus, connecting innovation with risk reduction, the UltraShot offers repeatability with pressure monitoring and traceability, so any issues are traceable and caught in real time. This virtually eliminates the ‘high-risk’ scenario. Medical companies often invest large amounts of money on part quality verification tools that offer post-mold measurements because their system is unable to sense whether parts are good or bad. With the UltraShot, the need for these expensive measurement tools can be eliminated. The UltraShot enables molders to design for part function instead of being limited by process capabilities, which leads to a higher quality and finer products. The assembly of medical parts has always been a risk for patients, meaning risk for scrap if the parts produced are unsuitable. Now product designs can be further optimized for function enabling a new quality and safety standard. With the UltraShot technology, this risk is eliminated.

Real-time process monitoring is so important and leads to better overall processes. With the UltraShot, Husky has combined multiple different control technologies into a single unit, taking monitoring information from the mold itself. This has enabled the company to make process adjustment decisions extremely quickly – far faster than in a typical molding cell. It is a fully closed loop communication process that includes remote monitoring to remotely log into these systems in facilities all over the world, and therefore provide ultimate support with direct access. This is another trend that has grown in unforeseen ways during the COVID-19 pandemic. With limited traveling ability, Husky’s engineers can act on information in real time. This holistic, full mold control solution reduces process risk significantly. CONCLUSION The melt delivery system is critical to the injection molding cell performance. With Ultrashot, Husky masters the delivery of plastic in a way that increases part design flexibility, while reducing risk and improving part quality and speed of mold qualification. It is the perfect fit for medical part producers looking to scale-up, implement more efficient process control, address competitive marketplaces, as well as reduce scrap, waste and cost.

salexand@husky.ca

Transforming the ways in which injection molding machinery performs required novel research and development methods. Husky therefore took a holistic look at the injection molding process, and especially at where the deficiencies were located. For the development of the UltraShot, these requirements had to be addressed head-on in order to develop a product that didn’t just advance injection molding processes, but a product that addresses market needs and deficiencies. With this product, Husky continues to show that it is well connected to the needs of its customers. CONNECTIVITY It also comes down to connectivity and smart manufacturing. The idea of connecting all equipment together to gather useful information, upon which manufacturers make decisions and recommendations, is key.

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R&D BUDGETS

Digital is pivotal SPEED, REDUCED COSTS, AND SUPPLY CHAIN AGILITY: PROTOLABS’ CHRIS STEVENS ASKS WHAT DIGITAL MANUFACTURING MEANS.

igital transformation is likely at the center of most business discussions today, yet many manufacturers still struggle in making the shift. Companies that don’t act with urgency risk being left behind fighting the ambiguity caused by the COVID-19 pandemic, rather than moving on to recovery. During this unprecedented time, transitioning organizations from crisis mode into operating in a new normal is paramount for employee retention. Working in crisis mode can only be maintained for so long before employee burn-out is inevitable. In addition, there are operational issues to address when shifting to digital technology. But the failure to take that step into the digital world, often known as Industry 4.0, is more detrimental to long-term company health than waiting to see what happens, either with the current pandemic crisis or with other factors that emerge.

The plastics industry is no exception. Navigating company transformations is a daunting task. This article discusses how to make that transformation to a digital manufacturing supply chain, and provides some key areas to consider when making the switch. WHAT IS INDUSTRY 4.0? Internet of things (IoT), artificial intelligence (AI), machine learning, digital twins, and robotics are no longer novel terms, yet the adoption rate remains relatively low. Industry 4.0, which I like to call Manufacturing 4.0, is not a ‘cookie-cutter’ approach but rather has numerous paths to achieving the goal of becoming more efficient and effective. Nailing down exactly what Manufacturing 4.0 is has always been a challenge, but most can agree that it is defined by the ability to capture, harness, and make good decisions from data. Fundamentally, Manufacturing 4.0 is having full visibility from raw material to finished goods, both for the product and process, what we like to call ‘The Digital Thread’. It is the manufacturing fingerprint that connects all aspects of the business to enable speed, quality, and cost without largely sacrificing one for the other two. These building blocks, coupled with smart

R&D BUDGETS

role of digital manufacturing is SIPOC (Supply, Input, Process, Output, Controls), which ensures the inputs and outputs are understood. Knowing the inputs and outputs of digital manufacturing will reduce errors, rework, and other costly missteps that can delay progress and whole projects. One of the most costly mistakes we see is submitted designs that don’t take into account the manufacturing process capabilities or our design for manufacturability (DFM) analysis that we provide at the quoting stage. This DFM analysis ensures that geometries will have fewer manufacturing-related issues. Engaging early in the design process to review DFM can reduce costly design changes down the road. devices, enable maximum output. Whichever term you prefer, we’re talking about fully automated, digital manufacturing. A strategy for a digitalized supply chain – what you can do today COVID-19 has introduced a oncein-a-lifetime mass disruption event that has drastically shifted the manufacturing and supply chain landscape in a short period of time. This has left many supply chains on life support and companies scrambling to repair critical-tobusiness arteries. Looking for new options or ways to improve supply chains to prevent a repeat of this year’s mayhem continues to be a top priority, with many looking at digitalization as the silver bullet. However, digital transformations are a journey, something not achieved overnight. Embarking without a strategy is almost certain to result in big challenges and missed opportunities. Leveraging digital manufacturing platforms allows designers, engineers, and supply chain professionals access to quick-turn manufacturing resources, such as injection molding, 3D printing, CNC machining, and sheet metal fabrication. This access to a quick-turn manufacturing supplier provides companies with flexible and agile manufacturing for a rapidly changing world. Using such platforms enables improved user experience, faster turnaround times, and parts in hand faster than traditional methods. A common lean tool that can help any organization understand the

Another common mistake is not leveraging tooling for more than prototyping. Advancements in the manufacturing process of molds has improved quality while keeping cost relatively consistent. This debunks the notion that prototype tooling is only useful for a few hundred shots. We continuously witness aluminum tools crossing over the 100,000 mark still molding quality parts. Leveraging this capability can help meet the needs of low-volume production without high-cost steel tooling designed to last for millions of cycles. Building further on that is using this tooling to bridge into product tooling while ramping product sales in parallel also for a strategy of accelerating products to market while controlling overall project costs. Companies that have recognized monumental gains in leveraging digital manufacturing platforms are those that have product development strategies that move all the way from prototype to production tooling. For example, companies like FOAM-it and Corindus leveraged digital manufacturing with the use of aluminum tooling for injection molding. This approach accelerated development and helped these companies adjust to demand uncertainties, all while minimizing large capital investments before the product was fully verified. Both saw short product development cycles and smoother transitions to production using a single source from prototype to production ramp. WHAT DOES THE FUTURE HOLD? One common mistake by business leaders in developing and launching new technologies, is building solutions in isolation without a clear vision of how they can generate business value as a whole. The ‘cool’ factor around IOT or digital transformations often gets us caught up in the moment thinking about the small piece versus the full puzzle. Ensuring the cart doesn’t end up before the horse is a cautionary tale from those that have embarked on the journey without keeping the full picture in mind. The future of digital manufacturing is bright and shows great strides toward leveling the global manufacturing playing field. The organizations that have kept the big picture in mind, seek to continuously understand the key role digital manufacturing plays and how it can unlock flexibility in operations, indeed how it can provide the ultimate level of flexibility. When dealing with any new technology or change to the norm, we must ensure we do not enter the analysis paralysis stage of decision making only to miss out on the opportunity in fear we might be making the wrong decision. Digital manufacturing is here to stay. The digital thread is what will enable innovative companies to harness the ability to flex with market demands, meet customer needs, and adapt to global shifts at a moment’s notice – whether it’s a pandemic or something else. Manufacturing has never been a more exciting industry to be in as advancements continue to bring solutions to complex problems.

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CONNECTED SURGICAL TRAINING

DEMAND FOR CONNECTED SURGICAL TRAINING IN A POST-COVID ERA DR ELLIOT STREET, CO-FOUNDER OF INOVUS MEDICAL, DISCUSSES HOW THE SURGICAL TRAINING MODEL IS EVOLVING TO MEET THE NEW DEMANDS OF THE COVID-19 PANDEMIC, AND HOW ADVANCED AUGMENTED REALITY AND ADDITIVE MANUFACTURING TECHNOLOGIES ARE PAVING THE WAY.

urgical simulation-based training for laparoscopic procedures has been gaining steady traction over the course of the last decade. Proving to be an effective and safe learning environment, the new approach to surgical education allows students to perform and record simulated â&#x20AC;&#x2DC;full surgical proceduresâ&#x20AC;&#x2122;, as well as basic skills tasks. Postgraduate medical education is now an even more worthwhile setting for surgical simulation-based training, given the plethora of new skills, technologies, and procedures that are introduced on a regular basis.

However, with the onset of the Covid19 pandemic, medical education stalled abruptly in April of this year. Elective lists and rotations were cancelled, and self-isolation posed a dilemma for the majority of trainee surgeons across the globe, with hospitals becoming out of bounds to all but emergency cases.

There are several factors driving the current demand for laparoscopic surgical simulation-based training. These include a shortage of surgical training sites to accommodate the increasing numbers of medical students, patient safety and the lack of readily available, extremely expensive, equipment for which to practise on.

THE VIRTUAL SOLUTION With surgeons unable to operate at their usual volumes, they are at increasing risk of skills fade. Social distancing measures have impacted the delivery of traditional surgical training with many simulation centres restricting numbers and contact; meaning that previous approaches to re skilling surgeons are now not possible. Over time, people have adapted to e-learning systems based on formalized teaching with the help of electronic resources so while teaching can be based in or out of the classrooms or offices, the use of computers and the internet forms the major component. The adoption of new technology therefore for surgical simulation training has followed this approach in the wake of rapidly growing demand for high fidelity connected learning during and post COVID-19. Other forms of technology, such as expensive VR systems, have been readily available on the market to offer simulated experiences. However, there is a need to hone skills in a risk-free environment with haptic feedback. The ability for connected learning with outcome focused reporting prior to patient interaction can only truly be achieved through AR (augmented reality) or MR (mixed reality) where virtual and real environments interact. As such, there is a real need for companies incorporating connected learning and haptic feedback into product development to offer surgical trainees the opportunity to train remotely, anywhere in the world, whether it be from a simulation centre, hospital or at home. That is what Inovus Medical

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CONNECTED SURGICAL TRAINING

has pioneered, with support and funding through SBRI Healthcare, funded by NHS England. The system allows patients to connect with their education provider through an online training platform, representing a paradigm shift in haptic realism utilising real feel soft tissue models and real laparoscopic instruments to provide unparalleled functionality. THE REALITY As mentioned, the need for ‘functional Augmented Reality’ or ‘Mixed Reality’ by merging real feel soft tissue models with digital anatomy and ensuring seamless interaction between both the digital and real environments, promises to provide future, significant value in surgical training. This new advanced form of simulation allows surgeons to practise a range of procedures across many surgical specialties. Instrument tracking technology enables the capture of instrument handling and performance metrics with performance data displayed on an online platform. The standard approach, therefore, of the more traditional laparoscopic box trainers, which many trainee surgeons are now familiar with and are widely manufactured and used across the globe, are being brought into the future with the development of ground-breaking technology and connected learning capability. With the addition of this new technology in advanced simulator production follows the requirement for scalable, affordable, manufacturing capabilities. MANUFACTURING THE FUTURE As demand for this new technology and new ways of training increases with more and more surgeons and surgical trainees now being encouraged to train from home so businesses have to source manufacturing techniques to keep up with this increase demand. Companies, such as Inovus Medical, are now turning to additive manufacturing, which enables the company to produce plastic parts with a finish level equivalent to that of injection molding but without the expensive up-front cost of tooling and manufacturing of injection molds.

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The use of SLS technology for manufacturing large scale commercially viable products is not something often seen with 3D printing, a technology that is widely used for rapid prototyping and small-scale projects but has found it difficult to translate into the wider manufacturing sector. However, Inovus Medical has taken a contrarian approach to deployment of the technology allowing the company to use SLS printing as a main stay in its manufacturing processes.

The adoption of new technology therefore for surgical simulation training has followed this approach in the wake of rapidly growing demand for high fidelity connected learning during and post COVID-19 15

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SMART MANUFACTURING

WEB INDUSTRIES’ VP OF CORPORATE DEVELOPMENT & MEDICAL, KEVIN YOUNG, AND MARKET DEVELOPMENT AND STRATEGY MANAGER, RALPH TRICOMI, EXPLAIN HOW EXPERIENCED CONTRACTORS CAN DRIVE PPE AND LFI TESTS RAPIDLY.

Knowledge puts the “smart” in smart-contract manufacturing

mart manufacturing means different things in different contexts. In the age of COVID-19, when US medical device manufacturers and makers of PPE are working under government mandates to reshore production of tests, gowns, masks and curtains from Asia, ‘smart’ means knowing how to earn Emergency Use Authorization (EUA) for the tests, ramp up production and bring a product to market in a hurry. COVID-19 tests and PPE supplies are direly needed and in short order to support getting the United States back to work. According to the National Institute of Health (NIH), needs for COVID-19 tests, for example, exceed 100 million per week. As a matter of national security, government initiatives to reshore PPE supplies include mandates that they be manufactured, or at least assembled, in the US. This immediate, critical and massive need for supplies and tests has prompted start-up companies to launch PPE manufacturing programs and for established medical device firms to pull back the overseas production they installed years ago. They must find ways to meet both government requirements and market demand quickly. Needs for knowledge, materials and equipment stand in their way. A case in point: Most start-ups are in the batch-production stage of making lateral flow immunoassay (LFI) tests. Typically, they have a limited amount of materials and a small collection of manufacturing equipment – enough only to generate a sample number of tests. They need assistance to transfer from batch to commercial-scale production. Established medical device businesses might or might not own the necessary manufacturing equipment. In many instances, equipment is in Asia, 10,000 miles away. Add to that needs to establish a supply chain for materials, reproduce low-variance manufacturing operations in the US, and manage the staggering amount of government regulations that oversee the manufacture of safe, FDA-certified medical-related product, and their mission is daunting, yet imperative. From start to finish, the product development to mass-market process can literally take years during the best of times.

WHERE TO TURN? US-based contract manufacturing organizations (CMOs) are one potential source. CMOs can field orders from OEMs and brands for the production or assembly of component parts. This can mean manufacturing components as unremarkable as non-woven elastic bands used to hold facemasks in place to converting highly specialized chemical-based test strips and then precisely assembling them in OEMs’ LFI COVID-19 plastic test cartridges. For many CMOs, the technical transfer of moving reagent production from batch to commercial quantities is a core competency. Understanding and successfully completing the many undertakings necessary to acquire EUA are just one competency example. Another is the ability to store data in ways that meet FDA rules and ensure that COVID-19 tests can be traced back through the supply chain to every step in the development, manufacturing and delivery process. Finding a CMO with an existing, mature PPE or medical device manufacturing process can eliminate the most complex challenges associated with rapid development, regulatory

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SMART MANUFACTURING

compliance, sourcing and delivery. Mature CMOs can usually adapt the roadmap they developed when creating their own mass-produced PPE products to bring a start-up’s or OEM’s PPE product to market in just a few months. Additionally, a CMO will likely have a supply chain that meets its customers’ needs or be in position to quickly assemble one with trusted vendors. Knowing that the CMO’s roadmap will be managed by professionals experienced in the administrative and physical jobs necessary to mass produce PPE and medical device products frees start-ups and OEMs to focus internal resources on their core competences. It leaves the jobs to the CMO experts. WHAT TO LOOK FOR Choosing a CMO that meets your business’ requirements calls for due diligence from design, operations, supply chain, logistics and financial perspectives. The one you pick should have a proven history of successfully working with its customers’ design engineering department during the product ideation stage. Such experience is crucial to rapid product development and design changes. Moreover, examine its competence in other relevant engineering disciplines. For example, in the COVID-19 test strip development and assembly example cited earlier, a CMO’s depth of chemical engineering expertise should at least complement that of its OEM or startup client. To support cost-effective scaling, a CMO’s highly automated production manufacturing capability will often exceed a start-up’s production capacity.

Understanding and successfully completing the many undertakings necessary to acquire EUA are just one competency example

To produce mask, gown and curtain components, a CMO’s plant should meet all ISO and safety standards and have a back-up contingency plan to bring capacity online in the event of a production disruption or unexpected demand for additional product. Likewise, a CMO’s financial soundness speaks to its success as a business and the likelihood that it will be prepared to accommodate additional development and production needs. Ask about the CMO’s terms for receiving payment and for paying its own suppliers. Requirements for especially short payment terms or excessively long pay-out terms with their suppliers might indicate a cash flow issue. Review the company’s balance sheet for financial stability. Also ask your prospective CMO if it has a disaster recovery plan in place. Are quality procedures established? Are there firm plans for continuous process improvement? PPE supply chain continuity is a particularly important issue both for today’s pandemic situation and for potential needs in a post-COVID-19 world. The deadly virus has issued a national and economic mandate for continuity of supply, and US PPE and medical device OEMs’ needs for supply predictability are greater than ever. So, evaluate your potential CMO’s supply chain, from materials source through to delivery methods. Ensure that it is sound. Ultimately, you are investing in not just a product, but in a virtual partner. The risk is significant but necessary for competing in the PPE and medical device markets in the age of COVID-19. Which brings us to a final criterion: Trust. The question of trust should be at the heart of all due diligence. Do you and your management ‘click’ with that of the CMO you are evaluating? Are your cultures compatible? Are you satisfied that this CMO will invest the same sense of purpose and commitment to success that your company does? Select the right CMO, and you will have a resource that helps slow the spread of COVID-19, supports putting the United States back to work and protects your business’ revenue stream.

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SMART MANUFACTURING

THE digital DIFFERENCE MPN MET WITH SCOTT DRIKAKIS, HEALTHCARE SEGMENT LEADER, AMERICAS AT STRATASYS, TO LEARN HOW COVID-19 HAS CATALYSED SMART MANUFACTURING.

Q&A HOW WOULD YOU DEFINE SMART MANUFACTURING? I would define smart manufacturing as using integrated technology systems on the potential of multiple shop floors that are connected to other business systems to improve manufacturing operations, decisionmaking and supply chain demand. It’s a broad concept, and like autonomous driving, it’s not all-ornothing. It’s a journey. DO YOU THINK SMART MANUFACTURING PLAYS A KEY ROLE WITHIN THE MEDICAL SECTOR? Yes, given the high value of medical sector products, it should be particularly appropriate. The cost of shortages is high, as we’ve seen in this pandemic, and it can even be life-threatening. Being able to plan and adapt manufacturing volumes and locations quickly is important. The value of these products is high, so waste is expensive, and IP is important. The pace of innovation is relentless, so manufacturing lines are frequently changing. Within the COVID-19 environment, all this relative unpredictability for critical products further reinforces the need for smart manufacturing. HOW DOES STRATASYS UTILISE SMART MANUFACTURING? We take digital files, load them directly into a 3D printer and convert them into parts, so it’s the most digitized way to manufacture anything. It can be centralized or decentralized based on the customer. Our goal is to make sure that customers gain all the

benefits from that digitization. Stratasys has led the effort to include support for additive manufacturing in the MTConnect standard, which enables customers using our F900 system to easily collect, analyze and display machine and sensor data from our systems. Last year, we announced a new cloud-based work order management solution, GrabCAD Shop to help our customers scale up their 3D printing operations. We also work with partners like Siemens to simplify the hand-off from manufacturing execution systems to 3D printers. When our customers add in automatic offload paths to our Stratasys Direct Manufacturing operation for parts on demand, they add digital scalable capacity when and where they need it. WHICH SMART MANUFACTURING PROCESSES HAS STRATASYS IMPLEMENTED TO HELP WITH COVID-19? In March, we launched an initiative to get thousands of 3D-printed face shields to front line workers, starting with an initial target of 5,000 by the end of the week. By June, we had shipped 275,000 shields, using a combination of 3D printing and injection molding. The operational heart of this effort was our GrabCAD Shop cloud software. We were able to use it to create a virtual 3D printing company that comprised our operations and those of dozens of our partners across the country. We ultimately had more than 150 companies and universities across the US in the coalition, including Medtronic, Raytheon and Boeing. Anyone with an FDM 3D printer was able to instantly start making shields with a digital file posted online, and connectivity to our cloud of partners through GrabCAD Shop – no tooling, no mold-making, just go. HOW WILL COVID-19 AFFECT SMART MANUFACTURING WITHIN THE MEDICAL SECTOR? I don’t believe the COVID-19 pandemic really created any new trends, but it helped accelerate awareness and opportunities that were already underway. One of the things we will likely see is the line between healthcare provider and medical products manufacturer start to blur, especially for spare parts. Essentially, hospitals can 3D print certain parts on-site. Digital rights management software integrated with 3D printers would essentially let the manufacturer get paid for parts without actually manufacturing them and shipping them. The customer does it on demand. The VA and the Mayo Clinic have implemented smart manufacturing at their healthcare facilities to improve patient experience and care. The largest hospital system in Europe, Assistance Publique – Hopitaux de Paris, or APHP, purchased 60 of our 3D printers last spring specifically to print parts they need on-site. The combination of connectivity, faster and more reliable 3D printers, and new software capabilities, will continue to encourage innovations like this.

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WHO ARE WE? BSI Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business. We have come a long way since being founded in 1901. Today, we’re a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services and the delivery of training courses. BSI Medical Devices Notified Body is a respected, world-class National Standards Body and Notified Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers around the world. Our teams apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others and we are proud to say that BSI are designated under the MDR and IVDR! A brief insight to regulations and standards: • ISO 13485 is an effective solution to meet the requirements for a Quality Management System (QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations whilst demonstrating a commitment to the safety and quality of their medical devices. • The Medical Device Single Audit Program (MDSAP) is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. • CE Marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is a legal requirement to place a device on the market in the EU. For more information you can access whitepapers, webinars and many more documents on our BSI website or by looking at our BSI Medical Devices page on LinkedIn.

Ever considered working for a leading Notified Body? We make a difference to the world every day. BSI are always on the look out for medical device experts to join us and make a difference in assessing, healthcare, testing, training and publishing.

Meet Marie- Sarah, one of our expert auditors! As a Medical Device Auditor, you’ll travel to medical device manufacturers across USA, Canada and occasionally Europe. You’ll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.

If you’re interested in a career with BSI please email Talent Acquisition team- careers@bsigroup.com to register your interest

LABELING

D E L E B LA SAFE

POLYFUZE DESCRIBES HOW FUSION LABELING CONTRIBUTES TO HEALTHCARE INDUSTRY COMMITMENTS THROUGH CREATING STERILE ENVIRONMENTS.

ithin every healthcare, medical, outpatient, nursing home, or hospital setting, there exists a mission to ensure patients are treated to the highest quality standards of care available, utilizing every technology, innovation, process, and standards available to help accomplish this goal. One way that hospitals contribute to this mission is to ensure each patient’s room is thoroughly cleaned and sanitized before, after, and throughout the duration of a patient’s hospital stay. This sanitization must include every fomite. Fomites are every stationary or non-living object such as floors, beds, handrails, chairs, doorknobs, clothing, and surfaces. Fomites attract bacteria or harmful microbes that then aid in the transmission of highly contagious bacteria, pathogens, or viruses that can lead to Healthcare Acquired Infections (HAIs). As of 2011, the World Health Organization found that in developed countries, 3.5% to 12% of hospitalized patients acquire at least one HAI, with about 4 million cases occurring annually in Europe, and a further 1.7 million cases in the USA. HAIs are considered preventable because thorough sanitization efforts, risk can be minimized. This article offers insight into how Polyfuze Graphics Fusion Labeling

Technology for medical plastics can help reduce the number of HAIs present in healthcare, hospital, outpatient, or nursing home settings. HAI PREVENTION THROUGH PLASTICS Through the widespread use of low surface energy polyolefin plastics in medical settings, HAIs can be more easily managed. This is because polyolefin plastic is an inherently inert material, meaning that once it is cleansed and sanitized, it can effectively and repeatedly be disinfected of harmful bacteria and microbes. Low surface energy (LSE) polyolefin plastic, such as that used in sharps containers, medical or biohazard waste containers, or regular trash cans, is widely utilized in the medical industry, and ideal for biomedical applications. It possesses a high level of durability and can withstand both heat and cryogenic freezing. For example, sharps containers must meet 600 cycles of high-temperature pressure washing, detergent cleaning and autoclaving. It’s inherent characteristic to be chemically inert means it is easily disinfected of bacteria or viruses that cause HAIs and spread infection. Once a plastic surface is wiped down with a disinfectant solution, any bacteria or virus on the surface of the plastic are easily killed and removed. LABELING AND HAIs While it is understood that LSE polyolefin plastics can simultaneously withstand harsh chemicals or hundreds of cleaning cycles such as autoclaving processes without any change in structural integrity, we often don’t think about what happens to the other labeling technologies adorning those plastics. These labels are critical, often conveying vital biohazard warnings and other essential information that needs to remain legible and fully attached to the surface of that plastic by law. Biohazard or warning labels used in the medical industry are required by law 29 CFR § 1910.1030 – Bloodborne pathogens, which states: ‘warning labels must be affixed to prevent loss or unintentional removal’. The battle is twofold, if the label fails, it cannot adequately or reliably convey critical safety information. Secondly, a label that fails can become the perfect breeding ground for infectious bacteria. For example, when damage occurs, either by the label’s failure to adhere or bond to polyolefin plastics or due to the damaging effects of disinfectants, detergents, cryogenic freezing, autoclaving or general use, the result is that the exposed edges, underlying layers, and gummy adhesives become the perfect environment to harbor HAI causing viruses and bacteria.

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LABELING

The labels are completely recyclable. So you have both the benefits of infection control and the ability to recycle the product at the end of its useful life Other labeling technologies only perpetuate this problem, with studies showing that reusable medical devices and infectious waste containers are potential sources of micro-organisms capable of causing infection in immunocompromised patients. Because these warning labels are meant to permanently convey critical information to healthcare workers and patients alike, the irony is that while these very labels’ sole purpose is to provide instruction on how to safely handle infectious waste or substances, the label has itself become the breeding ground for bacteria, and therefore unsafe for healthcare workers or patients to encounter. With 1.7 million affected patients (from HAIs), it’s important to recognize that there are improvements we can make to help ensure healthcare environments are safer for those who work and are treated in them. HOW POLYMER FUSION LABELING TECHNOLOGY CAN REDUCE HAIS Bob Spurgin, President at Spurgin Consulting Group LLC, has spent over 40 years working in the area of medical waste policy, permitting, technology evaluation and regulatory advocacy throughout the US and internationally. He is the co-author of the EPA Guide for Infectious Waste published in in 1980, and in 1990 he was the contractor for Finding the Rx for Managing Medical Waste – A Report to the US Congress. His work includes medical and pharmaceutical waste, Controlled Substances, RCRA hazardous and patient health information/confidential waste issues. Spurgin said: “It is important to recognize that public health and safety be of paramount consideration when dealing with this type of medical waste. When I looked at their method of labeling containers, I was impressed by a couple of things. Their stamping process does not include glues or adhesives that can trip micro-organisms. As a result, you can disinfect these containers and labels in an antimicrobial manner. The labels are also completely recyclable. So you have both the benefits of infection control and the ability to recycle the product at the end of its useful life.” Polymer Fusion Labeling Technology is unlike any other labeling method because it is designed with 100% LSE compatibility in mind.

gummy adhesives, or exposed under layers to harbor harmful bacteria or viruses. The labels can be reliably disinfected for the life of the part and thereby reduce the risk of HAI transmission. As HAI statistics show, it is important for the healthcare community to work together to invest in technologies that will work towards solutions to the complex problems that contribute to HAIs. By understanding the important role that medical labels play in healthcare settings, Polymer Fusion Labeling Technology was designed to produce medical labels that become one with the medical plastic component and take on the same characteristics. This results in medical labels that remain unscathed for the life of the part – a 100% chemically inert polymer able to withstand aggressive disinfectants and cleaning cycles, thereby addressing multiple problems that contribute to label failures and HAIs. Practical solutions, protocol, and innovation will lead the way to investing in technologies with the ability to improve our health and our lives.

Polymer Fusion labels are constructed of the same polyolefin plastic as the surface they fuse into. Using heat and pressure, they fuse molecularly into the subsurface of the plastic and therefore take on the same attributes of the polyolefin plastic medical products they’re fused into. Polymer Fusion Labels can also be manufactured with an added antimicrobial agent from BioCote that continuously fights bacteria right where it’s most needed, at the surface. Polymer Fusion Labels are inherently chemically inert, meaning they can be cleansed and sanitized with harsh chemicals repeatedly, and easily withstand hundreds of cycles of autoclaving or extreme heat/cryogenic freezing. Because the label and medical plastic surface become one cohesive part, the label is flush with the plastic surface, and there are no peeling edges,

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REGULATORY UPDATE

THE NEW CALIFORNIA MEDICAL WASTE LAW IMPACTS OUT-OF-STATE MANUFACTURERS AND DISTRIBUTORS WITH COSTLY COMPLIANCE MANDATES. SPENCER FANE LAWYERS KAREN OLSEN AND JON FARNSWORTH DISCUSS.

Sharpening up I

n late 2018, California passed a law that will, in the near future, present sweeping changes to the pharmaceutical industry and certain medical device manufacturers. The new law amends the existing California Integrated Waste Management Act and is expected to be a boom for medical waste disposal companies who stand to obtain significantly more business. While the law was signed by the California Governor nearly two years ago, the regulations will go into effect by 1 January 2021. The original bill, dubbed the ‘California Sharps and Drug Takeback Bill’, requires a manufacturer of covered drugs or home-generated sharps waste to offer safe disposal methods for their customers’ used and unused products.

If those figures are correct, it means that every year in California alone, there are nearly 400 million sharps that have the heightened risk of injuring sanitation workers and/or the general public because they are not being properly disposed of. In addition, many households dispose of prescription and non-prescription drugs by throwing them in the garbage or flushing them down the toilet, causing further health concerns. Who does this new law affect? ‘Covered Entities’ under the law include pharmaceutical and medical device manufacturers and distributors who sell or offer for sale their products in the State of California. ‘Covered Products’ include prescription and non-prescription drugs and home-generated sharps waste such as needles, lancets and other devices used to pierce a patient’s skin for the delivery of medication. Under the new law, Covered Entities are obligated to engage in a complex and costly stewardship plan for the takeback of covered drugs and homegenerated sharps waste from households that also requires an annual payment and report to CalRecycle, and registering its covered products. Once the stewardship plan is submitted, CalRecycle will review the plan and has the ability to approve, disapprove or conditionally approve the plan.

The law has a potentially sweeping affect because it encompasses all covered drugs and homegenerated sharps waste that are sold or offered for sale in California.

The stewardship plans must be submitted to CalRecycle by July 2021 and the take back programs are anticipated to be in place in late 2022 or early 2023.

California lawmakers championed the new law by citing to information from CalRecycle, which reported that nearly a billion sharps are used by California consumers every year and approximately a third of them are improperly disposed of in the trash. Another study conducted by

the University of Massachusetts Lowell, estimated that nearly seven per cent of sharps are flushed down a plumbing fixture.

The law does provide for a mail-back program of the applicable sharps waste for any counties where there is not an authorized collection site. The covered entity must make appropriate arrangements for the mail-back container to be of a sufficient size to hold all of the affected product purchased by the customer and the container must be provided for free, be preaddressed and include prepaid postage. CalRecycle has the ability to impose stiff penalties against those companies who violate the law, which include penalties of up to $50,000 per day if a violation is intentional, knowing or reckless (or otherwise up to $10,000 per day). While the California law potentially has wide-spread effects, medical device and pharmaceutical companies are not obligated to comply with the law with respect to sales that occur outside of the State of California. Nonetheless, the standards set by the California legislature may quickly become an industry best practice for medical waste disposal and other states may also follow suit.

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REGULATORY UPDATE

Harnessing consultant partnerships: A guide to outsourcing in the

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MAETRICS PRESIDENT STEVE COTTRELL SHARES HIS INSIGHTS ON HOW CONSULTING FIRMS CAN HELP LIFE SCIENCE COMPANIES MEET CHALLENGES.

rior to the pandemic, the medical device industry was already facing a changing regulatory landscape. The unfolding of the healthcare crisis and the consequent disruption brought to the table additional pressures for the life science industry. As quality and regulatory compliance teams seek to swiftly adapt to this changing backdrop, they must endeavor to allocate limited resources as efficiently as possible. In this context, a re-assessment of the balance between in-house capabilities and outsourcing relationships would prove highly beneficial to companies, not only to tackle current compliance pressures but also to strategically manage longer-term regulatory changes. In fact, the healthcare crisis is likely to speed up a growing trend towards outsourcing activities, with the whole medical device outsourcing market projected to reach €230bn (~$265bn) by 2027. This article aims to shine a light on how turning to experienced consulting firms will position companies in a better place to meet current and future challenges. Companies must be able to quickly adapt to rapid changes, while continuing to meet regulatory requirements. Regulatory changes brought about by the pandemic – such as the US Food and Drug Administration’s shift towards remote audits

– do not come without concerns for regulatory professionals, as new protocols require additional time to build in-house capacity and skills not yet in place. However, some temporary measures may become permanent, so it is essential to monitor evolving requirements, and adjust accordingly. As circumstances change, outsourcing platforms enable quick access to resources with the required skillset, when it is most needed. This frees up staff time to focus on the key areas they are able to – creating a flexible, strategic approach to managing capacity and the knowledge of your talent. STAYING ON TOP OF THE EU MDR With the recent delay to the Date of Application of the European Medical Device Regulation, now taking effect on 26 May 2021, manufacturers placing products on the European market have additional time to ensure compliance. In particular, this delay gives them the scope to thoroughly address some of the more challenging aspects of the regulation, such as reviewing their network of ‘Economic Operators’ and carrying out a proper review of their compliance documentation, including Clinical Evaluation Reports, Technical Files and Post Market Surveillance requirements. Being prepared for regulatory compliance gives companies a competitive advantage. With any new legislation or regulation, the industry will be experiencing a certain level of uncertainty on how to effectively meet EU MDR regulatory requirements. By leveraging experienced consulting firms who have been through regulatory change in the past, they can offer an inside view on best practices and efficient approaches to maintaining a high level of regulatory compliance. Moreover, the feedback they receive from notified bodies means they should have built up an effective industry benchmark to measure activities. OVERCOMING SUPPLY CHAIN DISRUPTIONS Disruption to the medical device supply chain also brings new challenges for life science companies. With many US and European production and supply capabilities in China, India and South East Asia, manufacturers will need to source alternative locations to secure product availability. This puts further strain on RA/QA professionals who will have to ensure compliance with design and validation requirements to enable device manufacturing in different locations. Against this backdrop, input from third party consultants with a footprint in multiple geographical areas will ease the pressure, allowing companies to continue their operations and keep supplying essential products to the market. In this rapidly evolving landscape, it is crucial for businesses to stay on top of their compliance activities. A strategic re-assessment of their resources and outsourcing strategies will help companies achieve greater levels of agility and scalability to better navigate the current context. Maetrics’ whitepaper on this topic - Strategy Review: a portrait of post pandemic pharmaceutical, diagnostic and medical device regulation - is available for download here: https://bit.ly/2QbQHNQ

References: Medium, Covid-19 impact: What is the Medical Device Outsourcing Market size?, 13 May 2020

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EXTRUSION

Putting on the RilSlix KAITLIN SULLIVAN, MARKETING MANAGER AT PUTNAM PLASTICS, INTRODUCES THE RILSLIX TECHNOLOGY FOR COATED MANDRELS AND WIRE FOR MEDICAL CATHETERS AND PROCESSING AIDS.

utnam Plastics has been a leader in the coating of guidewires and mandrels for medical device applications for nearly two decades. Our latest RilSlix coating technology for mandrels and wires is ideal for medical catheters and processing aids, and includes a range of fluoropolymer coatings on discrete, tapered and continuous wire.

Our RilSlix discrete mandrel and continuous wire coating technology is compatible with a variety of metals, including, but not limited to, stainless steel, silver plated copper, and Nitinol in diameters ranging from 0.010” to over 0.500” (0.254mm to 12.7mm). We can also accommodate discrete lengths up to 13 feet. Coating materials include thermoplastics, thermosets, and fillers. This coating technology offers a superior bond and allows for thicknesses between 0.00035” to 0.0007” (0.00889mm to 0.01778mm). These coatings are available for both discreet and continuous configurations to suit your medical device and catheter application needs.

Our proprietary compound, RilSlix, has been designed with PFOAfree, REACH and ROHS compliant materials and exhibits up to five times stronger adhesion of the coating to the mandrel than industry standards. The new RilSlix technology also offers unparalleled durability, which enables wires and mandrels to be used repeatedly without flaking. It also maintains a high release surface, offering an increased resistance from everyday nicks and dings. This grants a net cost benefit to customers over the lifetime use of the coated mandrels. The combination of performance, wear-resistance and longevity makes RilSlix-coated mandrels superior to fluoropolymer coated wires and mandrels, as well as a cost-effective option.

These coatings are available for both discreet and continuous configurations to suit your medical device and catheter application needs. EXPERT APPROVAL Catheter mandrels are not something one usually thinks about unless there is a problem with them. However, the new RilSlix mandrels are an exception. In the words of our own Senior Catheter Engineer here at Putnam Plastics, Bob St. John: “The ease of removing these mandrels from a reflowed shaft or a catheter tip assembly surpasses every other mandrel I’ve used over the past 30 years. The performance of the RilSlix mandrels exceed all of my expectations. You really have to try them to appreciate how good they are.” Putnam Plastics’ engineers are available to assist in material selection and optimization, ensuring that the polymer coating that is ultimately selected is best suited to meet specific product performance requirements. Samples are available in formats that will enable customers to evaluate bond strength, frictional properties and durability. Putnam also offers in-house testing for all adhesion and coating processes. By providing both manufacturing and testing under one roof, our customers benefit from a reduction in lead time and access to product design that is customer specific.

Our proprietary compound, RilSlix, has been designed with PFOA-free, REACH and ROHS compliant materials and exhibits up to five times stronger adhesion of the coating to the mandrel than industry standards

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WEARABLES - DUPONT

DUPONT’S JENNIFER GEMO, GLOBAL STRATEGIC MANAGER FOR HEALTHCARE, AND EUGENIO TOCCALINO, GLOBAL BUSINESS DIRECTOR, SHARE THE LAUNCH OF THE NEW LIVEO BRAND AND DISCUSS THE IMPORTANCE OF COLLABORATION, SCIENCE AND MATERIALS IN DESIGNING NEXT-GENERATION MEDICAL DEVICES.

SAVING LIVES WITH

WHICH INDUSTRY PLAYERS ARE HELPING WITH DUPONT’S PROJECTS AND COLLABORATIONS IN THE WEARABLE MEDICAL DEVICE SECTOR? JG: We play along the value chain so our strategy is really to foster co-operation with influencers and decision makers for materials that will make future medical devices. We’re working with leading medical device OEMs, with fabricators and converters, and we work more and more with design houses who are being consulted for building smarter devices. I would say that it’s critical for us to partner with these different stakeholders to make sure we bring the value at the early stage of the project to influence the design. In September 2020, we showcased at

Meddec in China a patch prototype that we developed with Holst Research Center in the Netherlands and Pronat Industries, a converter and patch maker based in Israel. This was a great three-way co-operation to build a new concept of a smart prototype for long-term monitoring where we combined the strength of our science and material expertise, Holst’s expertise in design, and Pronat’s expertise in processing and assembling the prototypes. This is a very powerful co-operation and the way forward to bring new tech to market. ET: Nobody can own all the pieces in the material device. Integrators are looking for expertise in electronics and materials. They look for those types of co-operation. You can get this very geographically diverse co-operation going very fast – the development was very quick. JG: We have this unique position in this market. Not only a leading player in medical devices, but serving the pharma solutions space and the biopharma processing space too. We intervene in different healthcare areas that may be served by similar types of companies – pharma companies and/or, medical device OEMs – and so we’re able to be the contact point of reference for our wide range of solutions. That’s very powerful. HOW HELPFUL WAS INPUT FROM SCIENCE? SPECIFICALLY FROM DERMATOLOGISTS? ET: Manufacturing is all done based on healthcare practices. We have FDA approval and our tech centers in the US, in Europe and in China are not tech centers as we normally call them – they are regulatory service centres too. Whatever we do needs to meet very stringent regulations. It is very important that we launch this new brand in China because in the past China was easily adopting industrial grades even for medical applications for external application. They were more easily accepting industrial grades, but now they’re getting new

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WEARABLES - DUPONT

regulatory requirements specific to healthcare. These new devices to transmit data on, which doctors make decisions or administer medication, you cannot fail there. You know every day when you develop and sell a new product that you are responsible for the lives of people. JG: That’s very relevant. Regulatory expertise enables us to help our customers in accelerating the registration of the new devices, bringing peace of mind because we are able to substantiate the quality of our products and helping them register theirs. DUPONT’S PREDICTIVE ENGINEERING: HOW HAS THAT HELPED TO AUGMENT WEARABLE DEVICES? JG: This is a corporate capability and service that we offer to customers that uses computer simulations to predict product behavior in the final device and influence the material specification from the early design stage. We leverage this capability in the drug delivery devices market where we can simulate how internal parts of the devices will react when submitted to a specific stress. We can then make recommendations of the material or influence the design of the device based on the constraints or application requirements. With these predictive tools and material science expertise, we can influence future design and co-operate with customers to understand their needs and adapt to their challenges. ET: If you look at the outer part of the device, if you use acetol, nylon or PBT, we do the engineering. So, we help the customer to do the design and we do prototyping. On the soft side, silicones are more like technical developments based on testing more than predictive engineering. We have the capacity to go in that direction as we do it normally for plastic. I think it’s an exciting time. This business comes from the heritage of Dow Corning, which is strongly known in the market coming from a merger between Dow and DuPont. Now we are really proud to launch the new brand, Liveo. From a business standpoint, we are leading in silicone healthcare. Fully specialised and serving three main downstream markets, the biggest of which is medical devices, where we see a lot of innovation and trends relating to the Internet of Medical Things and monitoring patients, administration of therapies and connected medical devices. This is a big area for us. Another big area is biopharma processing. It’s another revolution – the use of biologics – because the big molecules are the ones that are behind new vaccines, probably including the COVID vaccine. There is a lot work there and most of the new therapies in difficult-to-treat illnesses are done with biologics. In medical devices, we are mostly providing material that is transformed into parts or adhesives; in biopharma processing, we provide assemblies and connectors as we are a part producer there; and in pharma solutions, pretty much any patch you buy that contains silicone contains our product. We have a lot technology and expertise everywhere, and we need to make sure the active ingredients are safe. HOW REASSURING IS IT FOR PATIENTS TO LEARN THAT DUPONT IS BEHIND SO MANY MATERIAL INNOVATIONS? ET: I think our customers are very happy because they like to have the power of innovation and science in a large global organization. Between us and a local player, they would prefer to work with us because of our capability and strength. Our customers definitely value that. The beauty of it is that somewhere we are a direct supplier to the large Tier One pharma companies. On the consumer side, they might not know that DuPont is inside, but with the brand that we are launching and the communication platform that we are using, we’re using the web and webinars more extensively to get our communication across directly to

the consumer. We were talking more to the experts and specialists beforehand. JG: We are playing in very critical healthcare applications – lifesaving applications – and having a sustainable business and a long-term vision for healthcare – and very substantial investments – brings security to our customers and their patients. We’re there for the long term. We’ve been there for many years and we are committed to continuing this tradition in healthcare and making sure that we continue to serve our customers and their patients. Liveo is really a great moment for our company to showcase this longterm commitment. What is really exciting is that it is not a new name, but it really bridges from the longterm legacy of the Dow Corning heritage. We have a leading position there, and Liveo bridges into the future – into how we can influence the future of the industry, whether in medical device or biopharma, with cost-effective cleaner processes, or pharma solutions with topical and transdermal solutions.

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PACKAGING

UNLOCKING THE POTENTIAL FEA ENGINEER AT NELIPAK HEALTHCARE PACKAGING SAMUEL AMBOSTA DISCUSSES THE POSITIVE EFFECTS OF FEA AND SIMULATION ON MEDICAL PACKAGING QUALITY.

he FDA and other governing bodies are increasingly accepting simulation as a means to develop products more efficiently. Evidence-based engineering requires costly and timeconsuming rounds of physical testing. But shifting to intellectual-based approaches which use meaningful data generated via simulation (also known as Finite Element Analysis, or FEA) adds significant value and supports greater product innovation, reduces costs, improves sustainability and speeds time to market. WHAT IS FEA OR SIMULATION? Simulation is a numerical method for solving engineering and mathematical physics challenges. It can be used to analyze materials or objects, mimicking real-world manufacturing process with appropriate assumptions to find how stresses affect design in a 3D computing world. For medical device packaging design, it can be used to help determine points of weakness in a potential product, while reducing or sometimes even eliminating the need for resources to be spent on development of a physical prototype. Simulation analysis has long been used by the injection molding sector, and is now being adapted to meet the challenges of thermoformed healthcare plastics, presenting stakeholders with intellectual data to clearly verify, communicate and understand the complex information required to select valuable solutions efficiently. Simulation can give packaging engineers and their medical device OEM customers valuable information about the performance of a package design early in the process without investing in the creation of physical samples for experimenting/testing.

FEA not only has the power to efficiently solve real-world problems such as plastic thinning, cracked flanges, seal creep and product migration, but also reduces design churn, through models developed for thermoform packaging. It offers the opportunity to save valuable time, money and other resources and mitigates risk by exploring “what if” scenarios, allowing mechanical engineers and material scientists to predict outcomes and design safety factors accordingly, removing uncertainty from package designs and improving the speed to market. Simulation is also a powerful analytical tool for product investigation and root cause analysis to understand field failures of existing products in the market which have met customary testing standards. HOW SIMULATION WORKS Design and development teams can take a computer-generated CAD file, coupled with specified physical properties of the plastic, to create finite element models and predict the performance of the thermoforming and product integrity. With NeliSim Finite Element Analysis, two types of simulation may be performed: Thermo-Forming Simulation, which simulates the limitation of final product using minimal resources; and Transit-Test Simulation, which determines predictability in product performance during product integrity testing. This provides insightful data on factors such as minimum wall thicknesses; shows material deflections that may result in cracked flanges and seal creep; and leads to a better overall understanding of product limitations before entering physical testing protocols – leading to higher first-time-right outcomes. The engineering team can provide a simulated view of the complete package, as opposed to only assessing the performance of select components individually. Assessing the product as a whole provides a higher degree of confidence that the thermoformed piece is accurate to reality. DESIGNING FOR IMPROVED SUSTAINABILITY The transformative product development enabled through simulation may lead to improved sustainability and lower costs. By identifying critical to quality attributes (CQA) early and driving more optimal plug designs, simulation reduces unnecessary product components and raw materials usage. Additionally, effective simulation prevents unnecessary manufacturing and shipping of defective product. CONCLUSION: SIMULATION FOR PRODUCT DEVELOPMENT With the physical modeling and testing methods currently used by medical device companies, unforeseen issues may not materialize until late in the process, resulting in delayed lead times and additional costs. Use of simulation helps to reduce design churn, establish design best practices early on and ultimately helps bring effective products to market more expediently. By allowing customers to accurately assess predictability of packaging performance and have a better edge of failure understanding, in the end the customer gets a higher quality product.

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Medical Plastics News

Virtual Engineering Week: 30 November – 4 December 2020 1

Stellar conference line-up with speakers from Boston Scientific, Johnson & Johnson, Philips, Kablooe Design, and Siemens.

All-new digital event bringing best-in-class education and efficient networking.

Hundreds of virtual exhibitor booths spanning medtech, automation, design, packaging, and plastics.

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Velentium launches embedded cybersecurity training and certification

Smart Safe Science gets provincial funding to make masks

elentium has announced the launch of a new training and certification series, Mastering Embedded Cybersecurity.

world’s leading medical device manufacturers and their engineers on how to avoid and mitigate cybersecurity vulnerabilities.

The program has been created as a response to mounting threats as cybersecurity continues to play a larger role in medical device development. The training will establish standards and educate the

CEO Dan Purvis said: “Our security experts have worked tirelessly with regulatory and standard bodies to better define the tools, techniques, and processes for the medical device industry, giving us first-hand knowledge of the intricate security issues and increasing vulnerabilities facing the industry today. As soon as we began teasing this program, we received significant interest from some of the world’s leading players in the medical device field, demonstrating an urgent need for formal training on how to implement cybersecurity best practices and processes in pre-market and post-market activities.”

ntario-based medical technology manufacturer Smart Safe Science is receiving CAD 2m from the provincial government to produce innovative face masks for healthcare and frontline workers. A subsidiary of electronic interface maker True North Printed Plastics, Smart Safe Science plans to make a face mask that is lighter and more breathable. Called the 3S SmartMask, the device features a transparent shell that conforms to the wearer’s facial structure. The mask also comes with attachments that monitor body temperature while the person is wearing the mask, to allow the user to connect a smart device in the mask to their phone using an app that will transmit critical realtime data about the user’s health status.

W W W. M E D I C A L P L A S T I C S N E W S . C O M

As part of the development of the mask, Smart Safe said it drew upon technical expertise at several Ontario universities, including Lakehead University, Laurentian University, McMaster University, and the University of Toronto.

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COV3